A novel rapid combined RP-HPLC stability method development and validation for antiviral HIV combinations lamivudine, tenofovir, doravirine in dosage form and its application to in vitro dissolution

Abstract

In the analysis of the pharmaceutical agents new sophisticated chromatographic methods have been utilized for the quality control purpose. In the current scenario ample amount of new drugs and newer pharmaceutical formulations are available intended in the cure of diseases. Diseases like HIV, AIDs, Hepatitis, and other viral diseases requires newer drugs and their combinations. As a result of this there is a need for analyse the drugs for quality control purposes. Here the api-drugs Lamivudine LAM, tenofovir TEN, Doravirine DOR, has been analysed by the RP-HPLC method in the tablet dosage-forms. This method is developed for the analysis, of these three drugs in combined forms for rapid analysis with very less amount of analytes drugs utilized for analysis purposes. The concentration range for the linearity selected was 7.5 to 45 μg/ml for Lamivudine LAM & Tenofovir TEN, whereas for Doravirine DOR it is 2.5 to 15 μg/ml. Wavelength selected for estimation was 269nm and chromatographic column used was Acclaim 120 C-18 column (250 mm x 4.6 mm, 5 μm id). The Retention time obtained were 2.16min for LAM, 2.65min for TEN and 3.25min for DOR. The correlation coefficient was found to be 0.9999 and this method is utilized for, the chemical analysis of drugs in synthetic mixtures and in formulation. The Stability & forced-degradations studies are carried out in the different stress conditions and the impurities as well as pure drug substances are efficiently detected by the developed HPLC method.